Ascend granted certification for quality control testing at Munich facility

Ella Day | June 12, 2025 | News story | Contract Manufacturing, Manufacturing Services, Manufacturing and Production Adeno-associated (AAV)-based gene therapy., Ascend Advanced Therapeutics, Devices, Pharmacy, adeno-associated gene therapy, contract development and manufacturing organisation, good manufacturing practice certification, manufacturing site 

Ascend Advanced Therapies, a contract development and manufacturing organisation based in Maryland, US, has received good manufacturing practice (GMP) certification for quality control (QC) testing at its site in Munich, Germany. This will streamline testing and release of adeno-associated (AAV)-based gene therapy.

The Munich facility is now permitted to perform advanced commercial assays for DNA impurities, vector genome titre and capsid titre using advanced techniques, including droplet digital PCR and automated ELISA. These methods are advantageous over conventional approaches as they require smaller sample volumes, reducing manufacturing costs, while maintaining high-quality.

“The GMP certification enables streamlined stability testing and release of higher quality AAV-based gene therapy products,” said Karl Heller, vice president and head of the Munich site.

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Additional methods such as potency assays are planned to be added to the Munich GMP licence in the second half of 2025, while GMP expansions continue in Florida, US, to support Ascend’s global commercial activities.

“We will continue to make critical investments and build on this foundation to support customers at any stage of their development journey,” concluded Mike Stella, CEO at Ascend.

Ella Day
12/6/25

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